FIELD OF THE INVENTION
[0001] This invention relates to a prosthetic medical device and methods, and more particularly
to methods of connecting electrical conducting wires to a miniature implantable device
to minimize risk to the living tissue during and after surgery.
BACKGROUND OF THE INVENTION
[0002] Neurological disorders are often caused by neural impulses failing to reach their
natural destination in otherwise functional body systems. Local nerves and muscles
may function, but, for various reasons, such as injury, stroke, or other cause, the
stimulating nerve signals do not reach their natural destination. For example, paraplegic
and quadriplegic animals have intact nerves connected to functioning muscles and only
lack the brain-to-nerve link. Electrically stimulating the nerve or muscle can provide
a useful muscle contraction.
[0003] Further, implanted devices may be sensors as well as stimulators. In either case,
difficulties arise both in providing suitable, operable stimulators or sensors which
are small in size and in passing sufficient energy and control information to or from
the device, with or without direct connection, to satisfactorily operate them. Miniature
monitoring and/or stimulating devices for implantation in a living body are disclosed
by Schulman, et al. (U.S. Patent No. 6,164,284), Schulman, et al. (U.S. Patent No.
6,185,452), and Schulman, et al. (U.S. Patent No. 6,208,894).
[0004] It must be assured that the electrical current flow does not damage the intermediate
body cells or cause undesired stimulation. Anodic or cathodic deterioration of the
stimulating electrodes must not occur.
[0005] In addition, at least one small stimulator or sensor disposed at various locations
within the body may send or receive signals via electrical wires. The implanted unit
must be sealed to protect the internal components from the body's aggressive environment.
If wires are attached to the stimulator, then these wires and the area of attachment
must be electrically insulated to prevent undesired electric signals from passing
to surrounding tissue.
[0006] Miniature stimulators offer the benefit of being locatable at a site within the body
where a larger stimulator cannot be placed because of its size. The miniature stimulator
may be placed into the body by injection. The miniature stimulator offers other improvements
over larger stimulators in that they may be placed in the body with little or no negative
cosmetic effect. There may be locations where these miniature devices do not fit for
which it is desired to send or receive signals. Such locations include, but are not
limited to, the tip of a finger for detection of a stimulating signal or near an eyelid
for stimulating blinking. In such locations, the stimulator and its associated electronics
are preferably located at a distance removed from the sensing or stimulating site
within the body; thus creating the need to carry electrical signals from the detection
or stimulation site to the remote miniature stimulator, where the signal wire must
be securely fastened to the stimulator.
[0007] Further, the miniature stimulator may contain a power supply that requires periodic
charging or require replacement, such as a battery When this is the case, the actual
stimulation or detection site may be located remotely from the stimulator and may
be located within the body, but removed a significant distance from the skin surface.
By having the ability to locate the miniature stimulator near the skin while the stimulation
site is at some distance removed from the skin, the miniature stimulator and its associated
electronics can be more effectively replaced by a surgical technique or more efficiently
recharged through the skin by any of several known techniques, including the use of
alternating magnetic fields. If the electronics package is replaced surgically, then
it is highly desirable to have the capability to reconnect the lead wires to the miniature
stimulator via an easy, rapid and reliable method, as disclosed herein.
SUMMARY OF THE INVENTION
[0008] The instant invention relates to apparatus and methods for connecting an electrically
conductive wire to a miniature, implantable stimulator. The stimulator case is comprised
of electrically insulating materials such as plastic or ceramic. The plastic may be
epoxy, polycarbonate, or plexiglass. The ceramic may be alumina, glass, titania, zirconia,
stabilized-zirconia, partially-stabilized zirconia, tetragonal zirconia, magnesia-stabilized
zirconia, ceria-stabilized zirconia, yttria-stabilized zirconia, or calcia-stabilized
zirconia. There is at least one electrically conductive electrode for conducting electrical
signals. The materials comprising such electrically conductive parts are selected
to reduce or eliminate damage due to corrosion from the tissue environment surrounding
the miniature stimulator, and also to avoid damage to the tissue, for example, not
being toxic or having sharp corners that can damage the tissue.
[0009] The electrical connection between the electrically conductive case parts and the
electrically conductive wires is accomplished by several methods, including the use
of crimping, welding, threading, or interlocking by bayonet means, snap-on means,
screwing-on means, or pin means. The wire may also be secured to the electrode in
a variety of novel ways, including, compression fits between the cap and electrode
that secure the wire by compression fit.
[0010] The electrode may be either a male pin or a female receptor configuration. Apparatuses
for insulating the electrode from the body and for making attachment of a wire to
the electrode are disclosed. Some of these approaches to making safe and secure electrical
connections between and electrode and wire include bayonet mounting of the cap to
the electrode, crush lips to secure the wire between the cap and the electrode, and
spade clips to allow quick and secure attachment of the wire to the electrode.
[0011] In any of these approaches to making a secure and safe connection of wire to connector
attachment, the entire connection area and wire must be electrically insulated from
the body. Placing a flexible insulating boot over the entire stimulation wire connection
accomplishes this. The insulating boot is preferably held in place with at least one
of several methods, including ties, C-clips, silicone adhesive or a tight fit with
or without a securement ridge.
[0012] Each connection mechanism allows for the use of a wire with at least one separate
element, each of which may carry an independent electrical signal. Further multi-connector
slip cap or feedthrough apparatuses are disclosed which allow multiple independent
electrical connections to be made in a single maneuver during surgery.
[0013] This invention offers a variety of configurations to the surgeon, both pre-surgery
and during surgery. Changes may be made to the configuration to accommodate necessary
modifications during surgery and during secondary surgeries at a later time. Corrosion
is prevented or significantly reduced by the proper selection of materials and the
use of an electrically insulating boot in combination with secure attachment methods.
OBJECTS OF THE INVENTION
[0014] It is an object of the invention to provide an implantable miniature stimulator having
at least one electrode.
[0015] It is an object of the invention to provide a method of connecting at least one wire
to a miniature stimulator in a body.
[0016] It is an object of the invention to increase the ease and safety of a surgeon making
electrical connections for
in vivo application of a miniature implantable stimulator.
[0017] It is an object of the invention to connect the electrode of a miniature implantable
stimulator in a secure, safe and rapid fashion to electrical wires.
[0018] It is an object of the invention to electrically insulate the electrode of an implantable
miniature stimulator that is connected to an electrical wire from the body environment
in which it is implanted.
[0019] Other objects, advantages and novel features of the present invention will become
apparent from the following detailed description of the invention when considered
in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020]
FIG. 1 illustrates a perspective view of the miniature stimulator with a threaded connector
and nut.
FIG. 2 illustrates a perspective view of the miniature stimulator with a bayonet connector
and nut.
FIG. 3 illustrates a perspective view of the miniature stimulator with a pin connector and
nut.
FIG. 4 illustrates a perspective view of the smooth nut with a flare nut cap.
FIG. 5 is a cross-section through the flare nut wire insertion.
FIG. 6 is a cross-sectional view of the smooth cap with flare insertion.
FIG. 7 is a longitudinal section through the protective nut showing an offset mounting hole.
FIG. 8 is a cross-section through the protective nut showing the offset mounting hole.
FIG. 9 illustrates a stimulator with a hole and pin electrode.
FIG. 10 illustrates a stimulator with a hole and pin electrode and an electrode plug.
FIG. 11 is a longitudinal cross-section of a threaded hole electrode with plug.
FIG. 12 is a longitudinal cross-section of a threaded pin electrode with nut.
FIG. 13 is a longitudinal cross-section of a threaded pin electrode with nut and spade connector.
FIG. 14 illustrates a spade connector.
FIG. 15 illustrates a spade connector attached to a wire.
FIG. 15A illustrates a detailed section of the crimp of FIG. 15.
FIG. 15B illustrates a detailed section of an alternate crimp of FIG. 15.
FIG. 16 is a longitudinal cross-section of an electrode hole with a plug and crush lip.
FIG. 17 illustrates a C-clamp.
FIG. 18 illustrates a pin electrode with a wire inserted.
FIG. 19 illustrates a protective nut with a crush lip.
FIG. 20 is a longitudinal section through threaded insert with a flare attachment.
FIG. 21 is a perspective view of a stimulator in combination with a flare nut.
FIG. 22 is a longitudinal section showing the flare nut with a rubber boot.
FIG. 22A is a section showing tie interaction with the rubber boot of FIG. 22.
FIG. 23 is a top view of a disk-shaped miniature stimulator with electrodes.
FIG. 24 is a side view of a disk-shaped miniature stimulator with electrodes.
FIG. 25 illustrates a miniature stimulator annular electrode and a section through the annular
nut.
FIG. 26 is an end view of the miniature stimulator with annular electrodes.
FIG. 27 is an end view of the annular nut.
FIG. 28 is a longitudinal section through a miniature stimulator with annular electrodes
and a section through the annular nut.
FIG. 29 illustrates an end view of a plug with wires.
FIG. 30 is a longitudinal cross-section through a plug with wires installed in a hollow miniature
stimulator.
FIG. 31 illustrates a perspective view of an electrically conductive doorknob shaped electrode
with spring clip connector and wire.
FIG. 32 is a perspective view of the electrically conductive doorknob shaped electrode.
FIG. 33 is a perspective view of the spring clip connector.
FIG. 34 is a longitudinal section through the doorknob shaped connector with a wire and rubber
boot.
FIG. 35 is a longitudinal section through the doorknob shaped connector with crimped connector
a wire and rubber boot.
FIG. 36 is longitudinal section through the snap-on cap connector with rubber boot.
FIG. 37 is longitudinal section through the elongated snap-on cap connector with rubber boot.
FIG. 37A details the tooth interaction with the slip-on cap of FIG. 37.
FIG. 38 is longitudinal section through the flat-bottomed slot connector with rubber boot.
FIG. 39 is a perspective view of the flat-bottomed slot connector.
FIG. 40 is a perspective view of the flat-bottomed snap-on cap.
FIG. 41 is a cross-section of the flat-bottomed slot connector in the engaged position.
FIG. 42 is a cross-section of the flat-bottomed slot snap-on cap in the disengaged position.
FIG. 43 is a hand showing placement of an implantable miniature device with a wire lead that
carries electrical signals to a fingertip.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0021] An implantable miniature stimulator 2 is illustrated in
FIG. 1. FIG. 43 represents a typical placement of the implantable miniature stimulator 2 at a location
that is remote from the site that is to be stimulated, in this case a fingertip, where
an electrically conductive wire 38 carries the electrical signal to an electrode 39
at the stimulation site. Typical dimensions for this device are about 5 to 60 mm in
length and about 1 to 6 mm in diameter. (See, for example, U.S. Patent Nos. 6,164,284,
6,185,452, and 6,208,894 which are incorporated herein by reference in their entirety.)
While element 2 is generally described as a stimulator, it is recognized that the
present invention is equally applicable when element 2 is operable as a sensor or
as a stimulator and a sensor. Stimulator 2 includes insulating case 4, which typically
is hollow and contains an electronics package and a power source, such as a battery,
capacitor, magnetic field to electricity converter, and electrically conductive case
ends 6, each of which has an electrically conductive electrode 8 which conducts electrical
signals from a stimulator and/or to a sensor, depending upon the design and function
of that particular miniature stimulator 2. Stimulator 2 may have at least one electrode,
e.g., 2-8 or more, depending upon its particular design and function, although, for
illustrative purposes, only two electrodes are shown in
FIG. 1. Electrically conductive electrodes 8 are shown threaded in
FIG. 1, although alternate embodiments are shown in other figures and are discussed herein.
[0022] Insulating case 4 contains the electronics, which may include a battery or other
energy storage device and signal generating or receiving circuitry and is made of
an electrically insulating material that is capable of being hermetically sealed and
that is also biocompatible, such as plastic or ceramic. The plastic may be epoxy,
polycarbonate, or plexiglass. The ceramic may be alumina, glass, titania, zirconia,
stabilized-zirconia, partially-stabilized zirconia, tetragonal zirconia, magnesia-stabilized
zirconia, ceria-stabilized zirconia, yttria-stabilized zirconia, or calcia-stabilized
zirconia, and in a preferred embodiment, insulating case 4 is yttria-stabilized zirconia,
although other insulating materials may also be used. The insulating case 4 must be
a material that is biocompatible as well as capable of being hermetically sealed,
to prevent permeation of bodily fluids into the case.
[0023] The electrically conductive case end 6 is preferably a biocompatible, non-corrosive
material, such as titanium or a titanium alloy, although other metals such as platinum,
iridium, platinum-iridium, stainless steel, tantalum, niobium, or zirconium may be
used. The preferred material is Ti- 6 AI- 4 V. An alternate preferred material is
platinum-iridium.
[0024] If any electrically conductive electrode is not being used while the stimulator is
in the body, then the electrode may be insulated to prevent stimulation of nearby
tissue. Protective nut 10 is either an insulator or an electrically conductive conductor.
If it is an electrical conductor, then it is an extension electrode of electrically
conductive case 6. It is placed over the unused electrically conductive electrode
8 such that protective nut threaded hole 12 is tightly screwed onto threaded electrically
conductive electrode 8. In a preferred embodiment, the threads on threaded electrically
conductive electrode 8 are 0-80 threads. In order to avoid growth of tissue into joints,
such as the joint formed between protective nut 10 and electrically conductive case
end 6, it is preferable that any gap be less than 7 microns.
[0025] An alterative embodiment is illustrated in
FIG. 2 where bayonet electrode 14 is covered by protective nut 15 that contains bayonet
mount 16. Yet another embodiment of miniature stimulator 2 is illustrated in
FIG. 3, where electrically conductive electrode 8 is now stud electrode 21, a smooth stud,
which has electrode through-hole 18 passing radially through and intersecting with
the longitudinal axis of stud electrode 21. Stud protective nut 19 is placed onto
stud electrode 21 such that protective nut mounting hole 20 fits over stud electrode
21 while protective nut through-hole 22 is aligned with electrode through-hole 18.
Protective nut through-hole 22 is positioned such that it passes radially through
and intersects with the longitudinal axis of protective nut 19 and such that nut 19
fits very snugly against electrically conductive case end 6. Breakaway pin 24 is placed
into protective nut through-hole 22 and into electrode through-hole 18. After alignment
of protective nut 19 onto electrode 21 is complete, the protruding portion of breakaway
pin 24 is broken off and discarded.
[0026] A preferred method of attaching an electrically conductive wire 38 to a miniature
stimulator 2 (see
FIG. 1) is illustrated in
FIGS. 4, 5, and
6 wherein flare nut 26 is comprised of protective nut 28, which contains flare nut
mounting hole 30. Threaded flare nut mounting hole 30 is positioned over electrode
8 (see
FIG. 1) and tightened by screwing onto the threads. Flare nut 26 also contains flare nut
wire receptor 32 which has flare 34 on its extension pointed away from protective
nut 28. Because of the small diameter of wire used in this application, flare 34 is
provided for ease of placement of electrically conductive wire 38 into flare 34. Offset
through-hole 36 passes through flare nut wire receptor 32 in a plane that is perpendicular
to the longitudinal axis of flare nut 26. Offset through-hole 36 preferably does not
intersect with the longitudinal axis of nut 26, but is intentionally offset to penetrate
wire insulator 41 (see
FIG. 6) and to intersect with the outer diameter of wire conductor 40. Thus when a pin,
not illustrated, is placed in offset through hole 36, wire conductor 40 is contacted,
creating an electrically conductive path between wire conductor 40 and protective
nut 28.
[0027] The cross-sectional view of
FIG. 5 illustrates the offset alignment of offset through-hole 36 with respect to the longitudinal
axis of flare nut wire receptor 32. Wire conductor 40 is intersected by offset through-hole
36 such that wire insulator 41 will be penetrated and wire conductor 40 will be contacted
by a pin inserted in offset through-hole 36. Electrically conductive wire 38, shown
in
FIG. 6 is comprised of wire conductor 40 within wire insulator 41. Alternately, wire insulator
41 may be stripped from an end portion of wire conductor 40, to help insure good electrical
contact between conductor 40 and flare nut wire receptor 32.
[0028] In a preferred embodiment, wire conductor 40 is a highly conductive metal that is
also benign in the body, such as MP35, although stainless steel or an alloy of platinum-iridium
may also be used. Preferably, the wire has a diameter of approximately 0.003 inches.
It is contained in wire insulator 41 to electrically isolate it from the body tissue
and fluids and, in a preferred embodiment, wire insulator 41 is Teflon-coated silicone.
[0029] An alternate method of attaching an electrically conductive wire (not shown) to electrically
conductive case end 6 is shown in
FIG. 7, where an electrically conductive wire is attached to smooth stud electrode 21 by
placing smooth protective nut 42 over stud electrode 21 by aligning protective nut
mounting hole 43 with stud electrode 21 and engaging them. Offset through-hole 44
is of a diameter that allows an insulated wire to pass therethrough and it is aligned
such that when smooth protective nut 42 is pushed onto stud 21, the electrically conductive
wire is contacted and crushed, thereby making electrical contact between the electrically
conductive wire and stud electrode 21. A cross-sectional view through protective nut
42, illustrated in
FIG. 8, shows the alignment of offset through-hole 44 with respect to protective nut mounting
hole 43. Smooth protective nut 42 is retained on stud 21 by virtue of the frictional
force generated by a crushed wire present in offset through-hole 44 as protective
nut 42 is placed on stud electrode 21.
[0030] In an alternate embodiment, shown in
FIG. 9, miniature stimulator 2 has at one end threaded electrically conductive electrode
8 and at the other end threaded electrode hole 46. Alternate embodiments contain various
combinations of electrically conductive electrodes 8 and electrode holes 46.
FIG. 9 illustrates one such combination of dissimilar electrodes. As discussed previously,
if an electrode is unused, then it must be covered and protected to prevent tissue
damage or undesirable tissue growth into the stimulator. If threaded electrode hole
46 is unused, then it is filled with electrode plug 48, which is screwed tightly into
hole 46, as illustrated in
FIG. 10.
[0031] A further method of attaching an electrically conductive wire 38 (not illustrated)
to electrically conductive case end 6 is illustrated in
FIG. 11, where threaded electrode hole 46 mates with smooth nut 52 by inserting threaded
insert 50 into threaded electrode hole 46. As nut 52 is tightened, an electrically
conductive wire, not illustrated, that has previously been inserted in smooth nut
through-hole 54 is crushed between electrically conductive case end 6 and nut crush
lip 56, thereby making contact between the electrically conductive wire and electrically
conductive case end 6. Smooth nut through-hole 54 retains the wire in position and
assures that the wire is secured in place until smooth nut 52 is fully tightened.
[0032] Illustrated in
FIG. 12 is an alternate embodiment of a method of attaching an electrically conductive wire
to a miniature stimulator 2, wherein electrically conductive case end 6 has threaded
electrically conductive electrode 8 attached thereto. Electrically conductive electrode
8 contains electrode through-hole 18 located proximate to electrically conductive
case end 6. Protective nut 10 is attached to threaded electrically conductive electrode
8 by screwing electrically conductive electrode 8 into protective nut threaded hole
12. An electrically conductive wire, not shown, is held in place by placing it through
electrode through-hole 18. The wire makes electrical contact with electrically conductive
case end 6 by virtue of being crushed between electrically conductive case end 6 and
protective nut 10 by nut crush lip 56.
[0033] A further embodiment of methods to attach an electrically conductive wire (not illustrated)
to assure electrical conductivity between the electrically conductive wire and the
electrically conductive case end 6 is illustrated in
FIG. 13, where spade clip 58, which is attached to an electrically conductive wire (not illustrated),
is securedly fastened between protective nut 10 and electrically conductive case end
6.
[0034] Spade clip 58 is shown in
FIG. 14 with tab 60 configured to attach to electrically conductive wire 38. Electrically
conductive wire 38, is placed in tab 60 with wire insulator 41 stripped from an end
portion of the electrically conductive wire 38, thereby exposing wire conductor 40
for electrical contact with tab 60. Tab 60 is wrapped around electrically conductive
wire 38 so as to assure that electrically conductive wire 38 is securely attached
to spade clip 58 by wrapped tab 60, which has crimp 70, as shown in
FIG. 15.
[0035] FIG. 15 illustrates spade clip 58 with electrically conductive wire 38 attached to spade
clip 58 and retained by crimp 70. Opening 62 in spade clip 58 is configured to approximate
the diameter of electrically conductive electrode 8 (see
FIG. 13) such that spade clip 58 fits over electrically conductive electrode 8 (not illustrated).
In a preferred embodiment, tab 60 and electrically conductive wire 38 are oriented
at a right angle to spade clip 58, thus assuring that electrically conductive wire
38 is parallel to the longitudinal axis of miniature stimulator 2, thereby minimizing
stresses in the wire.
FIGS. 15A and
15B illustrate detailed alternate crimp 70 attachment methods of securedly fastening
wire conductor 40 to spade clip 58.
[0036] An alternate embodiment, illustrated by cross-sectional view in
FIG. 16, has a wire (not shown) placed through smooth nut through-hole 54, which is located
proximate to smooth nut 52. As smooth nut 52 is tightened into threaded electrode
hole 46 by inserting threaded insert 50 into threaded electrode hole 46, the wire
is crushed between end crush lip 72 and cap 52, thereby making electrical contact
between the wire and electrically conductive case end 6. The difference between the
method of wire attachment illustrated in
FIG. 11 and that shown by
FIG. 16 is the relocation of nut crush lip 56 from the protective nut 10 of
FIG. 11 to electrically conductive case end 6, as end crush lip 72 in
FIG. 16.
[0037] Illustrated in
FIGS. 18 and
19 is a further embodiment of a method of attaching an electrically conductive wire
(not shown) to miniature stimulator 2, wherein smooth electrode 76 contains no threads
and also has offset electrode through-hole 75, which is aligned to lie in a plane
that is perpendicular to the longitudinal axis of miniature stimulator 2 to intersect
with the outer diameter of wire conductor 38, such that when a pin (not shown) is
placed in through-hole 75, it will contact wire conductor 40, either by penetrating
wire insulator 41 or by contacting the wire conductor 40 directly, if wire insulator
41 has been stripped from that area. Protective nut 10, shown in
FIG. 19, illustrates nut crush lip 56, and also illustrates offset protective nut mounting
hole 77, which aligns with offset electrode through-hole 75, thereby allowing a pin
(not shown) to pass through both offset protective nut mounting hole 77 and offset
electrode through-hole 75.
[0038] A further embodiment, illustrated by cross-sectional view in
FIG. 20, is similar to the embodiment presented in
FIG. 4, but with electrically conductive case end 6 having threaded electrode hole 46 in
place of flare nut mounting hole 30. Threaded insert 50 is screwed into threaded electrode
hole 46, thereby securing protective nut 28 to electrically conductive case end 6.
An electrical connection between electrically conductive wire 38 is made by stripping
wire insulator 41 from the end of wire 38 thus exposing wire conductor 40. Conductor
40 is inserted into flare nut wire receptor 32 using flare 34 as a guide. Wire insulator
41 is stripped such that, when wire conductor 40 is inserted fully into flare nut
wire receptor 32, wire insulator 41 extends approximately one-quarter of the length
of receptor 32 into receptor 32. Wire 38 is securedly attached inside receptor 32
by crimping receptor 32 to wire conductor 40.
[0039] An alternate method of attaching protective nut 28 to smooth stud electrode 21 is
illustrated in
FIG. 21. While the preferred method of attaching the two components is by screwing them together,
as illustrated in
FIGS. 4 and
20, in the instant embodiment, electrically conductive case end 6 has stud electrode
21 attached thereto, which has no threads. Protective nut 28 slips snugly over stud
electrode 21 until electrically conductive case end 6 is located touching adjoining
protective nut 28. As previously illustrated in
FIG. 20 and as discussed above, wire 38 and its conductor 40 and wire insulator 41 are securely
fitted inside flare nut wire receptor 32 by using flare 34 as a guide. Electrically
conductive wire 38 is secured by crimping flare nut wire receptor 32 onto wire conductor
40 (see
FIG. 21). Protective nut 28 is secured to stud electrode 21 by placing C-clip 74 (see
FIG. 17) over protective nut 28 such that protective nut 28 is partially deformed, thereby
creating a secure attachment between stud electrode 21 and protective nut 28.
[0040] The preferred method of assuring electrical insulation between electrically conductive
case end 6, electrically conductive electrode 8, protective nut 28, and wire 38, as
illustrated in
FIG. 22, is to cover the electrically conductive case end 6 and other parts with rubber boot
82. Rubber boot 82 is made of a flexible insulating material that is biocompatible,
such as silicone. Its purpose is to provide electrical insulation such that stray
electrical signals do not pass between surrounding tissue and any electrically conductive
part of the device. Rubber boot 82 is secured to the device, preferably by tying it
in place with ties 84. A sufficient number of ties 84 are placed by the surgeon to
assure that that the rubber boot 82 will not move. It is preferred that at least one
tie 84 and, preferably two or more ties 84, be placed on rubber boot 82 to secure
rubber boot 82 to insulating case 4, so as to electrically insulate electrically conductive
case end 6 from the living tissue.
FIG. 22A illustrates a typical tie 84 interacting with rubber boot 82, so as to establish
and maintain a hermetic seal. Alternate methods of attaching rubber boot 82 include
the use of ridges inside rubber boot 82, clamps over rubber boot 82, silicone adhesive
inside rubber boot 82, ridges on the outside of insulating case 4, a male notch with
matching female indentation forming an O-ring seal, and the tight fit of rubber boot
82 over the device, either with or without internal ridges.
[0041] An alternate configuration to miniature stimulator 2, previously illustrated in
FIG. 1, is miniature disk stimulator 86, which is illustrated in
FIGS. 23 and
24. Disk 88 is preferably comprised of insulating material having at least one electrically
conductive electrode 90. Two electrodes are illustrated in
FIGS. 23 and
24, but alternate arrangements have at least one, e.g., 1 to 8 or more, electrodes. Electrode
90 is hermetically bonded to disk 88. Electrode 90 can be one or more tabs as shown
in
FIG. 23, or it can be one or more flush electrodes (not illustrated) that are mounted on the
surface of disk 88. While the tabs 90 that are illustrated in
FIGS. 23 and
24 project from the surface of the insulating disk 88, the tabs 90 can equally well
not project from the surface of insulating disk 88 and may be contiguous with the
surface such that they do not project above the surface. The methods of connecting
a wire to the miniature stimulator that have been previously discussed are equally
applicable to miniature disk stimulator 86, as well as to other configurations. The
dimensions of disk 88 are about 5 to 40 mm diameter and about 1 to 6 mm thick. Electrically
conductive electrode 90 is preferably made of an electrical conductor that is biocompatible
and corrosion resistant, such as platinum, iridium, platinum-iridium, tantalum, titanium
or a titanium alloy, stainless steel, niobium, or zirconium. Disk 88 is made of an
electrical insulator that is biocompatible, such as ceramic, glass, or plastic.
[0042] FIG. 25 illustrates an alternate annular electrode arrangement on the end of miniature stimulator
2. At least one annular electrode may be used, e.g., four annular electrodes 92 are
illustrated in
FIG. 25. Each annular electrode 92 is capable of carrying an independent electrical signal
and is electrically isolated from the other electrodes. The signal from or to stimulator
2 passes along electrically conductive wires 38, where each electrically conductive
wire 38 carries an independent signal and is electrically isolated from the others.
Each electrically conductive wire 38 corresponds with and is connected to one annular
electrode 92 by means of its connecting to toroidal spring 98. Alternatively, toroidal
spring 98 may be a semi-circular spring. Annular cap 94 contains toroidal springs
98. Electrically conductive wires 38 pass through holes in the end of cap 94. The
internal diameter of annular cap opening 96 approximates but is slightly larger than
the outer diameter of stimulator 2. To make a connection between annular electrode
92 and toroidal spring 98, annular cap 94 is pushed in a longitudinal direction along
the axis of stimulator 2 until it is fully engaged in a position such that electrical
contact is made between annular electrode 92 and a corresponding toroidal spring 98.
Each toroidal spring 98 is preferably retained inside annular cap 94 by an annular
recession inside annular cap 94 such that during engagement of stimulator 2 with annular
cap 94, the toroidal spring 98 is forced into the recession, thereby allowing room
for smooth engagement of the parts. The alignment of toroidal spring 98 and annular
electrode 92 is such that each toroidal spring 98 contacts only one corresponding
annular electrode 92.
[0043] FIG. 26 illustrates the case end 100 of stimulator 2 and
FIG. 27 illustrates the end view of annular cap 94. A cross-sectional view of annular electrode
92 is illustrated in
FIG. 28.
[0044] Another embodiment for making an electrical connection to miniature stimulator 2
is illustrated in
FIGS. 29 and 30. FIG. 29 illustrates an end view of electrode plug 104 (see
FIG. 30) showing four electrically conductive wires 38 passing into the center of electrode
plug 104 through potting material 106. The potting material provides a secure, hermetic
seal for wires 38 to pass into miniature stimulator core 102, as illustrated in
FIG. 30.
[0045] FIG. 30 illustrates a longitudinal view in cross-section of miniature stimulator 2 comprising
insulating case 4, electrically conductive case end 6, electrode plug 104, and potting
material 106. Electrode plug 104 is made of a biocompatible material such as titanium
and is attached by weld 105 to electrically conductive case end 6, thereby forming
a hermetic seal.
[0046] Another embodiment for making an electrical connection to a miniature stimulator
2 is illustrated in
FIG. 31 where doorknob electrode 108 is intimately attached to electrically conductive case
end 6. The doorknob electrode is made of a material that is electrically conductive
and biocompatible, such as titanium. Spring clip 110 is preferably a clip made of
titanium which has two or more, and preferably three or four prongs. Wire insulator
41 is stripped from the end of wire 38 thereby exposing wire conductor 40. Wire conductor
40 is preferably attached to spring clip 110 by strain relief weld 112. Strain relief
weld 112 helps to relieve strain in wire conductor 40 by virtue of being oriented
perpendicular to the longitudinal axis of miniature stimulator 2. Further strain relief
is provided in wire conductor 40 by virtue of it being tightly coiled inside wire
insulator 41 thereby forming wire strain relief 114. The inside of wire insulator
41 is fill material 115, which is preferably soft silicone, to minimize infiltration
of body fluids and other tissue inside wire 38.
[0047] A perspective view of doorknob electrode 108, showing its end attached to electrically
conductive case end 6, is illustrated in
FIG. 32. FIG. 33 illustrates a perspective view of spring clip 110 showing the four prongs that slip
over doorknob electrode 108 to form an electrical connection.
[0048] FIG. 34 illustrates spring clip 110 together with electrically conductive wire 38, which
in turn is attached by strain relief weld 112 to wire conductor 40. Spring clip 110
is shown in its attached position on doorknob electrode 108. Rubber boot 82 is securely
fastened to the device with ties 84 to completely cover electrically conductive case
end 6, doorknob electrode 108, wire conductor 40 and a portion of wire insulator 41,
thus electrically insulating the body tissue from electrical signals.
[0049] An alternate embodiment is presented in
FIG. 35, which is similar to the connection device presented in
FIG. 34 except that connector crimp 118, which is selected from the group of biocompatible
materials, and is preferably platinum metal, is placed over the end of electrically
conductive wire 38 so as to cover a portion of wire insulator 41 and stripped wire
conductor 40. Connector crimp 118 is attached to electrically conductive wire 38 by
crimping it onto wire 38.
[0050] A preferred embodiment is shown in
FIG. 36 in which slip-on cap 122 has a slightly larger internal diameter of a portion of
slip-on cap 122 such that it slips over the outer diameter of insulating case 4. Snap-on
cap 120 has at least one flexible member 130 having a tooth 135 on each flexible member
130. Tooth 135 engages the edge of electrically conductive slip-on cap 122, as illustrated
in
FIG. 37A, and holds snap-on cap 120 tightly in place. Electrical conductivity is achieved between
electrically conductive wire 38 and electrically conductive slip-on cap 122 by spring
disk 125 holding enlarged end of wire 140 tightly in contact with electrically conductive
slip-on cap 122 when snap-on cap 120 is in place. Rubber boot 82 provides electrical
insulation by covering electrically conductive slip-on cap 122, snap-on cap 120, and
a portion of electrically conductive wire 38.
[0051] An alternate embodiment is shown in
FIG. 37 in which snap-on cap 120 is elongated and slotted on the end opposite tooth 135.
When slotted elongated end 123 is squeezed, flexible members 130 are levered outward
and tooth 135 is thereby disengaged from the edge of slip-on cap 122.
FIG. 37A illustrates the interaction of tooth 135 with slip-on cap 122 such that snap-on cap
120 is securedly fastened to slip-on cap 122.
[0052] An alternate embodiment is shown in
FIG. 38 in which electrically conductive case end 6 contains at least one angled flat 150
to allow rotatable cap tooth 136 of rotatable cap 133 to slide smoothly onto the end
of electrically conductive case end 6 and to facilitate alignment of rotatable cap
tooth 136 with flat-bottomed slot 145. Electrically conductive case end 6 has at least
one flat-bottomed slot 145 that engages rotatable cap tooth 136 of rotatable cap 133
to retain rotatable cap 133 on electrically conductive case end 6. When rotatable
cap 133 is rotated about its longitudinal axis by about 30° to 90°, rotatable cap
tooth 136 is rotatably moved out of flat-bottomed slot 145, thereby allowing rotatable
cap 133 to be removed. These elements are shown in the perspective views of
FIGS. 39 and
40, the angled flat 150 is indicated to facilitate placement of rotatable cap 133 onto
electrically conductive case end 6 in order to engage rotatable cap tooth 136 with
flat-bottomed slot 145.
[0053] A cross-sectional view, through flat-bottomed slot 145 and perpendicular to the longitudinal
axis, is presented in
FIGS. 41 and
42. The view of
FIG. 41 indicates the position when rotatable cap 133 is in position to engage rotatable
cap tooth 136 with flat-bottomed slot 145. The view of
FIG. 42 indicates the same cross-sectional view as in
FIG. 41 but rotatable cap 133 has been rotated 90° from the position illustrated in
FIG. 41 to disengage rotatable cap tooth 136 from flat-bottomed slot 145 thereby allowing
removal of rotatable cap 133.
[0054] These various embodiments are of devices and methods for connecting an electrically
conductive wire to a miniature, implantable stimulator in order to efficiently transmit
or receive an electrical signal that is associated with the implantable stimulator.
[0055] Obviously, these methods of attaching a wire to a miniature implantable stimulator
can be used in permutations and combinations not specifically discussed herein. Many
modifications and variations of the present invention are possible in light of the
above teachings. It is therefore to be understood that, within the scope of the appended
claims, the invention may be practiced otherwise than as specifically described.
[0056] The following numbered paragraphs (paras.) contain statements of broad combinations
of the inventive technical features herein disclosed:-
1. An improved structure for communicating electrical signals between living tissue
and an implantable miniature device configured for monitoring and/or affecting body
parameters, wherein said miniature device has an axial dimension of less than about
60 mm and a lateral dimension of less than about 6 mm and at least one end of said
implantable device includes at least one electrically conductive surface coupled to
electrical circuitry contained within, said improvement comprising:
at least one electrically conductive case end comprised of at least one doorknob electrode
for communicating electrical signals between the living tissue and said implantable
miniature device by means of at least one electrically conductive wire having a first
end configured for electrical coupling to a selected portion of the living tissue
and a second end configured for coupling to said implantable miniature device;
at least one electrically conductive connector for attaching said at least one electrically
conductive wire to said at least one doorknob electrode; and
an insulating rubber boot surrounding said at least one electrically conductive case
end, said at least one electrically conductive electrode, and said at least one electrically
conductive connector.
2. The improved structure of para. 1 wherein said at least one electrically conductive
case end is a material selected from the group consisting of titanium, titanium alloy,
platinum, iridium, platinum-iridium, zirconium, niobium, stainless steel, and tantalum.
3. The improved structure of para. 1 wherein said at least one electrically conductive
case end is comprised of Ti-6AI-4V.
4. The improved structure of para. 1 wherein said at least one doorknob electrode
is a material selected from the group consisting of titanium, titanium alloy, platinum,
iridium, platinum-iridium, stainless steel, tantalum and niobium.
5. The improved structure of para. 1 wherein said insulating rubber boot is comprised
of silicone.
6. The improved structure of para. 1 wherein said at least one electrically conductive
connector comprises a spring clip.
7. The improved structure of para. 6 wherein said spring clip has at least one prong
for grasping said doorknob electrode.
8. The improved structure of para. 6 wherein said spring clip is a material selected
from the group consisting of titanium, titanium alloy, platinum, iridium, platinum-iridium,
stainless steel, tantalum and niobium.
9. The improved structure of para. 1 wherein said at least one electrically conductive
connector comprises a structure having at least one prong for grasping said doorknob
electrode.
10. A method of communicating electrical signals between living tissue and an implantable
miniature device configured for monitoring and/or affecting body parameters, comprising:
snapping an electrically conductive connector over a doorknob electrode that is attached
to an electrically conductive surface on an implantable miniature device;
attaching an electrically conductive wire having a first end configured for electrical
coupling to a selected portion of the living tissue and a second end configured for
coupling to said doorknob electrode;
implanting said first end of said electrically conductive wire where it is in contact
with the living tissue; and
implanting said miniature implantable device in the living tissue at some distance
from said first end of said electrically conductive wire.
11. A spring clip connector adapted to receive a doorknob electrode for communicating
electrical signals between living tissue and an implantable miniature device configured
for monitoring and/or affecting body parameters, comprising:
at least one prong for grasping said doorknob electrode,
a connection to at least one electrically conductive wire having a first end configured
for electrical coupling to a selected portion of the living tissue and a second end
configured for attachment to said spring clip, and
wherein said spring clip is a biocompatible material.
12. The spring clip connector of para. 11 wherein said biocompatible material is selected
from the group consisting of titanium, titanium alloy, platinum, iridium, platinum-iridium,
stainless steel, tantalum and niobium.
13. An improved structure for communicating electrical signals between living tissue
and an implantable miniature device configured for monitoring and/or affecting body
parameters, wherein said miniature device has an axial dimension of less than about
60 mm and a lateral dimension of less than about 6 mm and at least one end of said
implantable device includes at least one electrically conductive surface coupled to
electrical circuitry contained within, said improvement comprising:
at least one electrically conductive case end comprised of at least one doorknob electrode
for communicating electrical signals between the living tissue and said implantable
miniature device by means of at least one electrically conductive wire having a first
end configured for electrical coupling to a selected portion of the living tissue
and a second end configured for coupling to said implantable miniature device;
a means for attaching said at least one electrically conductive wire to said at least
one doorknob electrode, and
an insulating rubber boot surrounding said at least one electrically conductive case
end, said at least one electrically conductive electrode, and said at least one electrically
conductive connector.
14. The improved structure of para. 13 wherein said means for attaching said at least
one electrically conductive wire to said at least one doorknob electrode comprises
a spring clip.
15. The improved structure of para. 14 wherein said spring clip is a material selected
from the group consisting of titanium, titanium alloy, platinum, iridium, platinum-iridium,
stainless steel, tantalum and niobium.
16. The improved structure of para. 14 wherein said spring clip has at least one prong
for grasping said doorknob electrode.
17. The improved structure of para. 13 wherein said at least one electrically conductive
case end is a material selected from the group consisting of titanium, titanium alloy,
platinum, iridium, platinum-iridium, zirconium, niobium, stainless steel, and tantalum.
18. The improved structure of para. 13 wherein said at least one electrically conductive
case end is comprised of Ti-6AI-4V.
19. The improved structure of para. 13 wherein said at least one doorknob electrode
is a material selected from the group consisting of titanium, titanium alloy, platinum,
iridium, platinum-iridium, stainless steel, tantalum and niobium.
20. The improved structure of para. 13 wherein said insulating rubber boot is comprised
of silicone.
21. An implantable miniature device having a sealed elongated housing with an axial
dimension of less than about 60 mm and a lateral dimension of less than about 6 mm,
comprising:
an electrically insulating case which contains electronics in a hermetic environment;
at least one electrically conductive case end which communicates electrical signals
with tissue in a living body;
at least one connector for attaching at least one electrically conductive wire for
communicating electrical signals between said at least one electrically conductive
case end and tissue in a living body; and
an insulating rubber boot surrounding said at least one electrically conductive case
end, said at least one electrode, and said at least one connector to avoid affecting
body tissue proximate to said implantable miniature device.
22. The implantable miniature device of para. 21 wherein said insulating case comprises
a ceramic.
23. The implantable miniature device of para. 22 wherein said ceramic is alumina,
glass, titania, zirconia, stabilized-zirconia, partially-stabilized zirconia, tetragonal
zirconia, magnesia-stabilized zirconia, ceria-stabilized zirconia, yttria-stabilized
zirconia, or calcia-stabilized zirconia.
24. The implantable miniature device of para. 21 wherein said insulating case is a
plastic.
25. The implantable miniature device of para. 24 wherein said plastic is epoxy, polycarbonate,
or plexiglass.
26. The implantable miniature device of para. 21 wherein said at least one electrically
conductive case end is titanium, titanium alloy, platinum, iridium, platinum-iridium,
zirconium, niobium, stainless steel, or tantalum.
27. The implantable miniature device of para. 21 wherein said at least one electrically
conductive case end comprises Ti-6AI-4V.
28. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode is titanium, titanium alloy, platinum, iridium, platinum-iridium,
stainless steel, tantalum or niobium.
29. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode is threaded.
30. The implantable miniature device of para. 29 wherein said at least one connector
is a flare nut containing a flare nut mounting hole and flare nut wire receptor.
31. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode is smooth.
32. The implantable miniature device of para. 31 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
smooth electrically conductive electrode is at least one smooth protective nut containing
a protective nut mounting hole and a protective nut through hole.
33. The implantable miniature device of para. 32 wherein said at least one smooth
protective nut is held in place on said at least one smooth electrically conductive
electrode by at least one C-clip.
34. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode comprises at least one bayonet electrode.
35. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode comprises a threaded hole.
36. The implantable miniature device of para. 35 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
electrically conductive electrode comprises at least one smooth nut.
37. The implantable miniature device of para. 36 wherein said at least one smooth
nut contains at least one nut crush lip for making electrical contact with said at
least one electrically conductive wire and said at least one smooth nut contains a
smooth nut through-hole for receiving said wire.
38. The implantable miniature device of para. 35 wherein said at least one electrically
conductive case contains at least one end crush lip to facilitate making electrical
contact with said at least one electrically conductive wire.
39. The implantable miniature device of para. 35 wherein said at least one threaded
hole electrode, when unused, is filled with at least one electrode plug.
40. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode comprises at least one annular electrode.
41. The implantable miniature device of para. 40 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
annular electrode comprises at least one annular cap containing at least one toroidal
spring connector.
42. The implantable miniature device of para. 21 wherein said at least one electrically
conductive case end comprises at least one electrode plug with potting material through
which said at least one electrically conductive wire passes.
43. The implantable miniature device of para. 21 wherein said at least one electrically
conductive case end comprises at least one slip-on cap.
44. The implantable miniature device of para. 43 wherein said at least one connector
for attaching at least one electrically conductive wire to said slip-on cap comprises
at least one snap-on cap.
45. The implantable miniature device of para. 44 wherein said at least one snap-on
cap has a slotted elongated end for releasing said snap-on cap from engagement with
said slip-on cap.
46. The implantable miniature device of para. 21 wherein said at least one electrically
conductive case end contains at least one flat-bottomed slot.
47. The implantable miniature device of para. 46 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
flat-bottomed slot comprises at least one rotatable cap containing at least one tooth
for engagement with said at least one flat-bottomed slots.
48. The implantable miniature device of para. 47 wherein said number of at least one
teeth for engagement with said at least one flat-bottomed slots is equal to the number
of said flat-bottomed slots.
49. The implantable miniature device of para. 46 wherein said at least one electrically
conductive case end contains at least one angled flat to enable the rotatable cap
to slip onto said at least one electrically conductive case end.
50. The implantable miniature device of para. 49 wherein said number of at least one
electrically conductive case ends is equal in number to the number of said at least
one angled flats.
51. The implantable miniature device of para. 21 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
electrically conductive electrode comprises a flare nut.
52. The implantable miniature device of para. 21 wherein said at least one connector
for attaching a wire to said at least one electrically conductive electrode comprises
at least one spade clip.
53. The implantable miniature device of para. 21 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
electrically conductive electrode comprises at least one spring clip.
54. The implantable miniature device of para. 21 wherein said at least one connector
for attaching said at least one electrically conductive wire to said at least one
electrically conductive electrode is covered with an electrically insulating protective
nut, when said electrode is not in use as an electrode.
55. The implantable miniature device of para. 21 wherein said at least one electrically
conductive electrode comprises at least one slip-on cap.
56. The implantable miniature device of para. 55 wherein said connector for attaching
said at least one electrically conductive wire to said at least one electrically conductive
electrode comprises a snap-on cap.
57. The implantable miniature device as in para. 56 wherein said at least one electrically
conductive snap-on cap for attaching said at least one electrically conductive wire
to said at least one electrically conductive electrode has at least one slotted elongated
end for ease of removal of said snap-on cap.
58. An implantable miniature device having a sealed elongated housing with an axial
dimension of less than about 60 mm and a lateral dimension of less than about 6 mm,
comprising:
an electrically insulating case which contains electronics in a hermetic environment;
an electrically conductive case end at each end of said electrically insulating case
which communicates electrical signals with living tissue;
means for connecting at least one electrically conductive wire, which communicates
electrical signals between tissue in a living body and said electrically conductive
case ends; and
an insulating rubber boot surrounding said electrically conductive case end, said
at least one electrically conductive electrode, and at least one connector.
59. An implantable miniature device having a sealed elongated housing with an axial
dimension of less than about 60 mm and a lateral dimension of less than about 6 mm
and an electrically insulating case which contains electronics in a hermetic environment,
comprising:
an electrically conductive case end at each end of said electrically insulating case
for communicating electrical signals between tissue in a living body;
said at least one electrically conductive electrode comprises at least one slip-on
cap;
at least one electrically conductive connector for attaching said at least one electrically
conductive wire to said at least one electrically conductive electrode via at least
one snap-on cap; and
an insulating rubber boot surrounding said at least one electrically conductive case
end and said at least one electrically conductive connector.
60. An improved structure for communicating electrical signals between tissue in a
living body and an implantable miniature device configured for monitoring and/or affecting
body parameters, wherein said miniature device has an axial dimension of less than
about 60 mm and a lateral dimension of less than about 6 mm and at least one end of
said implantable device includes an electrically conductive surface coupled to electrical
circuitry contained within, said improvement comprising:
at least one electrically conductive wire having a first end configured for electrical
coupling to a selected portion of said living body and a second end configured for
coupling to said implantable miniature device;
means for connecting said second end of said at least one electrically conductive
wire to said at least one electrically conductive end; and
an insulating boot surrounding said at least one electrically conductive case end
and said connection means to electrically insulate said at least one electrically
conductive case end and said connection means to thereby avoid affecting body tissue
proximate to said implantable miniature device.
61. An improved structure for communicating electrical signals between tissue in a
living body and an implantable miniature device configured for monitoring and/or affecting
body parameters, wherein said miniature device has an axial dimension of less than
about 60 mm and a lateral dimension of less than about 6 mm, said improvement comprising:
an electrically conductive case end coupled to electrical circuitry contained within
for communicating electrical signals between tissue in a living body and said implantable
miniature device by means of at least one electrically conductive connector;
wherein said electrically conductive connector for attachment of said at least
one electrically conductive wire is a rotatable cap having at least one rotatable
cap tooth on at least one flexible finger,
said electrically conductive case end contains at least one flat-bottomed slot,
that is suitable for engagement with said at least one rotatable cap tooth, and at
least one angled flat to facilitate placement of said rotatable cap on said electrically
conductive case end; and
an insulating rubber boot surrounding said electrically conductive case end and
said at least one electrically conductive connector to thereby avoid affecting body
tissue proximate to said implantable miniature device.
62. The improved structure of para. 61 wherein the number of said at least one angled
flats is equal to the number of said at least one rotatable cap teeth.
1. An implantable miniature device having a sealed elongated housing with an axial dimension
of less than about 60 mm and a lateral dimension of less than about 6 mm, comprising:
an electrically insulating case which contains electronics in a hermetic environment;
at least one electrically conductive case end further comprising at least one electrically
conductive electrode which communicates electrical signals with tissue in a living
body;
at least one connector for attaching at least one electrically conductive wire for
communicating electrical signals between said at least one electrically conductive
case end and tissue in a living body; and
an insulating rubber boot surrounding said at least one electrically conductive case
end, said at least one electrode, and said at least one connector to avoid affecting
body tissue proximate to said implantable miniature device.
2. The implantable miniature device of claim 1 wherein said insulating case comprises
a ceramic.
3. The implantable miniature device of claim 1 wherein said insulating case is a plastic.
4. The implantable miniature device of any one of claims 1 to 3 wherein said at least
one electrically conductive case end is titanium, titanium alloy, platinum, iridium,
platinum-iridium, zirconium, niobium, stainless steel, or tantalum.
5. The implantable miniature device of any one of claims 1 to 3 wherein said at least
one electrically conductive case end comprises Ti-6AI-4V.
6. The implantable miniature device of any one of claims 1 to 5 wherein said at least
one electrically conductive electrode is titanium, titanium alloy, platinum, iridium,
platinum-iridium, stainless steel, tantalum or niobium.
7. The implantable miniature device of any one of claims 1 to 6 wherein said at least
one electrically conductive electrode is smooth.
8. The implantable miniature device of any one of claims 1 to 7 wherein said at least
one electrically conductive electrode comprises at least one bayonet electrode.
9. The implantable miniature device of any one of claims 1 to 7 wherein said at least
one electrically conductive electrode comprises a threaded hole.
10. The implantable miniature device of any one of claims 1 to 9 wherein said at least
one electrically conductive electrode comprises at least one annular electrode.
11. The implantable miniature device of any one of claims 1 to 10 wherein said at least
one electrically conductive case end comprises at least one electrode plug with potting
material through which said at least one electrically conductive wire passes.
12. The implantable miniature device of any one of claims 1 to 11 wherein said at least
one electrically conductive case end comprises at least one slip-on cap.
13. The implantable miniature device of any one of claims 1 to 12 wherein said at least
one electrically conductive case end contains at least one flat-bottomed slot.
14. The implantable miniature device of any one of claims 1 to 13 wherein said at least
one connector for attaching said at least one electrically conductive wire to said
at least one electrically conductive electrode comprises a flare nut.
15. The implantable miniature device of any one of claims 1 to 14 wherein said at least
one connector for attaching said at least one electrically conductive wire to said
at least one electrically conductive electrode is covered with an electrically insulating
protective nut, when said electrode is not in use as an electrode.
16. The implantable miniature device of claim 1 wherein said at least one electrically
conductive electrode comprises at least one slip-on cap.
17. An implantable miniature device having a sealed elongated housing with an axial dimension
of less than about 60 mm and a lateral dimension of less than about 6 mm, comprising:
an electrically insulating case which contains electronics in a hermetic environment;
an electrically conductive case end at each end of said electrically insulating case
which communicates electrical signals with living tissue;
means for connecting at least one electrically conductive wire, which communicates
electrical signals between tissue in a living body and said electrically conductive
case ends; and
an insulating rubber boot surrounding said electrically conductive case end, said
at least one electrically conductive electrode, and said means for connecting said
wire and said case ends.
18. An implantable miniature device having a sealed elongated housing with an axial dimension
of less than about 60 mm and a lateral dimension of less than about 6 mm and an electrically
insulating case which contains electronics in a hermetic environment, comprising:
an electrically conductive case end at each end of said electrically insulating case
for communicating electrical signals between tissue in a living body;
at least one electrically conductive electrode attached to said case end further comprising
at least one slip-on cap;
at least one electrically conductive connector for attaching at least one electrically
conductive wire to said at least one electrically conductive electrode via at least
one snap-on cap; and
an insulating rubber boot surrounding said at least one electrically conductive case
end and said at least one electrically conductive connector.
19. An improved structure for communicating electrical signals between tissue in a living
body and an implantable miniature device configured for monitoring and/or affecting
body parameters, wherein said miniature device has an axial dimension of less than
about 60 mm and a lateral dimension of less than about 6 mm and at least one end of
said implantable device includes an electrically conductive surface coupled to electrical
circuitry contained within, said improvement comprising:
at least one electrically conductive wire having a first end configured for electrical
coupling to a selected portion of said living body and a second end configured for
coupling to said implantable miniature device;
means for connecting said second end of said at least one electrically conductive
wire to said at least one electrically conductive end; and
an insulating boot surrounding said at least one electrically conductive case end
and said connection means to electrically insulate said at least one electrically
conductive case end and said connection means to thereby avoid affecting body tissue
proximate to said implantable miniature device.
20. An improved structure for communicating electrical signals between tissue in a living
body and an implantable miniature device configured for monitoring and/or affecting
body parameters, wherein said miniature device has an axial dimension of less than
about 60 mm and a lateral dimension of less than about 6 mm, said improvement comprising:
an electrically conductive case end coupled to electrical circuitry contained within
for communicating electrical signals between tissue in a living body and said implantable
miniature device by means of at least one electrically conductive connector;
wherein said electrically conductive connector for attachment of at least one
electrically conductive wire is a rotatable cap having at least one rotatable cap
tooth on at least one flexible finger,
said electrically conductive case end contains at least one flat-bottomed slot,
that is suitable for engagement with said at least one rotatable cap tooth, and at
least one angled flat to facilitate placement of said rotatable cap on said electrically
conductive case end; and
an insulating rubber boot surrounding said electrically conductive case end and
said at least one electrically conductive connector to thereby avoid affecting body
tissue proximate to said implantable miniature device.
21. The improved structure of claim 20 wherein the number of said at least one angled
flat is equal to the number of said at least one rotatable cap teeth.